Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT00806260
Eligibility Criteria:
Inclusion Criteria:
* Written consents;
* Adequate contraception from screening through 28 days after the last dose of study drug for female subjects;
* Healthy obese or overweight subjects with BMI between 27 and 35.
Exclusion Criteria:
* History of glaucoma or any past or present use of medications to treat increased intraocular pressure;
* Current use of any tobacco products, including cigarettes, cigars, pipes, or chewing tobacco, or use within the three months prior to screening;
* History of drug abuse during the three years prior to screening;
* History of alcohol abuse, or excessive alcohol consumption, or describes themselves as non-users of alcohol;
* Current depression of moderate or greater severity, or any presence or history of suicidal behavior or active suicidal ideation
* More than one lifetime episode of major depression;
* Currently working night shifts at a job;
* On average consumes greater than two cups of coffee or xanthine-containing beverages per day (\>200 mg/day) within the two weeks prior to screening;
* Any use of dietary, herbal, and/or fitness/body-building supplements (with the exception of vitamins) within one month prior to screening;
* Aspartate aminotransferase or alanine aminotransferase \>2.5 x ULN;
* Serum creatinine ≥1.5 mg/dL for men or ≥1.4 mg/dL for women.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
45 Years
Study:
NCT00806260
Study Brief:
Protocol Section:
NCT00806260